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NCT06884865 | RECRUITING | Osteoarthritis (OA) of the Knee

A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
Sponsor:

Pacira Pharmaceuticals, Inc

Brief Summary:

The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. It will also learn how the body reacts to the PCRX-201 injection and how effective the treatment is. Researchers will compare Dose A and Dose B of PCRX-201 versus placebo from Week 1 through Week 52 to assess adverse events. Researchers will also explore how PCRX-201 may impact knee pain and joint function over time. Participants will be asked to * Visit the clinic for pretreatment and drug administration * Visit the clinic for checkups and tests: 1. Screening through Week 52: intially weekly, bi-weekly, later monthly 2. Week 53 through Week 260 (Year 5): 8 visits throughout the period

Condition or disease

Osteoarthritis (OA) of the Knee

Intervention/treatment

Enekinragene Inzadenovec (PCRX-201)

Placebo

Phase

PHASE2

Detailed Description:

The study will consist of two parts, Part A and Part B, which will use PCRX-201 from two different manufacturing processes. A total of 135 eligible subjects, with painful OA of the index knee will be enrolled. Subjects will be randomly assigned to a treatment dose group, stratified by Kellgren-Lawrence (K-L) Grade, in both parts of the study. Enrollment of subjects with K-L Grade 4 will be capped at 4 subjects per dose group in Part A and 8 subjects per dose group in Part B. Enrollment of subjects with K-L Grade 2 or 3 will include a minimum of 4 subjects per Grade per dose group in Part A and a minimum of 8 subjects per Grade per dose group in Part B. This study does not require an equal number of subjects between K-L Grade 2 and 3. All eligible subjects will be pretreated with the same dose of methylprednisolone acetate (40 mg) on Day 1 immediately before treatment with PCRX-201 or placebo. Part A will enroll approximately 45 subjects into 3 dose groups (15 subjects in each treatment group, stratified by K-L Grade as noted above). Part B will enroll approximately 90 subjects into 3 groups (30 subjects in each treatment group, stratified by K-L Grade as noted above). Enrollment in Part B is dependent upon the availability of study drug developed with manufacturing process 2.

Study Type : INTERVENTIONAL
Estimated Enrollment : 135 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 2, Two-Part, Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Tolerability of Enekinragene Inzadenovec (PCRX-201) in Subjects With Painful Osteoarthritis of the Knee
Actual Study Start Date : 2025-02-26
Estimated Primary Completion Date : 2027-03
Estimated Study Completion Date : 2032-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Subjects must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions.
  • * Subjects must be male or female and 45 to 80 years old, inclusive, at Screening.
  • * Subjects must exhibit symptoms associated with osteoarthritis of the index knee for ≥12 months before Screening (subject self-reporting is acceptable).
  • * Subjects must have index knee pain for \>15 days over the last month before Screening (subject self-reporting is acceptable).
  • * Subjects must have failed 2 or more therapies: Restricted physical activity as per Osteoarthritis Research Society International (OARSI) core level recommendation, ie, "structured land-based exercise" (this may include physical therapy), and failure of an additional type of conservative therapy for OA of the index knee, eg, nonselective NSAIDs or COX-2 inhibitors, in the past 12 months.
  • * Subjects must have a body mass index (BMI) ≤40 kg/m2 at Screening.
  • * Subjects must have an index knee examination indicating the index knee and the intended injection site area are free of any signs of local or joint infection at Baseline.
  • * Subjects must have an index knee Average Daily Knee Pain (NRS) between ≥5.0 and ≤9.0 at Screening and Baseline.
  • * Sexually active subjects of child-bearing potential (SOCBP) and their partners must agree to use effective birth control while in the study
  • * Subjects must have active synovitis in the index knee as determined by ultrasound Doppler.
  • * Subjects must exhibit American College of Rheumatology Criteria (clinical and radiological) for osteoarthritis as follows
    • 1. Knee pain
    • 2. At least 1 of the following
      • i. Age \>50 years ii. Morning stiffness \<30 minutes iii. Crepitus on knee motion c. Osteophytes
      • * Subjects must have K-L Grade 2, 3, or 4 in the index knee based on X-rays performed during Screening and confirmed by trained radiographers at a central facility before enrollment
      • * Subjects need to show the presence of moderate or severe synovitis based on 11-point synovitis score using contrast-enhanced MRI
      Exclusion Criteria
      • * Subjects have any current or prior diagnosis of autoimmune connective tissue disorders, secondary OA conditions, benign synovial tumors, gout/pseudogout, reactive arthritis, RA, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
      • * Subjects have any active systemic or local infection, including infection of the index knee
      • * Subjects are unable to undergo MRI with contrast MRI
      • * Subjects with X-ray or MRI exclusionary events
      • * Subjects have an unstable index knee joint (eg, torn anterior cruciate ligament) within 12 months of Screening
      • * Subjects have used any approved or investigational IA drug/biologic in index knee within 6 months of Screening (eg, hyaluronic acid, platelet rich plasma, stem cells, prolotherapy, and amniotic fluid injection)
      • * Subjects are receiving or have received any gene therapy treatment (eg, IL-1Ra) in the past 3 years
      • * Subjects have used IA steroids ≤3 months before screening
      • Other protocol-defined criteria apply
A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee

Location Details

NCT06884865

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

Osteoporosis Medical Center

Beverly Hills, California, United States, 90211

RECRUITING

United States, California

Beach Physicians Medical Group Inc.

Huntington Beach, California, United States, 92647

RECRUITING

United States, California

Horizon Clinical Research

The table, California, United States, 91942

RECRUITING

United States, California

Alliance Clinical West Hills (Focus Clinical Research)

West Hills, California, United States, 91307

RECRUITING

United States, Florida

Arrow Clinical Trials

Daytona Beach, Florida, United States, 32117

RECRUITING

United States, Florida

Journey Research Inc.

Oldsmar, Florida, United States, 34677-4681

RECRUITING

United States, Florida

Palm Beach Research Center

West Palm Beach, Florida, United States, 33409

RECRUITING

United States, Florida

Conquest Research

Winter Park, Florida, United States, 32789

NOT YET RECRUITING

United States, Idaho

Injury Care Research, LLC

Boise, Idaho, United States, 83713

RECRUITING

United States, Nebraska

Physicians Research Collaboration

Lincoln, Nebraska, United States, 68516

RECRUITING

United States, Nevada

Excel Clinical Research

Las Vegas, Nevada, United States, 89109

NOT YET RECRUITING

United States, New York

The scientific

Brooklyn, New York, United States, 11235-3919

RECRUITING

United States, Pennsylvania

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, South Carolina

Clinical Trials of South Carolina - Charleston

Charleston, South Carolina, United States, 29406

RECRUITING

United States, South Carolina

Clinical Trials of South Carolina - Columbia

Columbia, South Carolina, United States, 29206

RECRUITING

United States, Texas

Zenos Clinical Research

Dallas, Texas, United States, 75230

RECRUITING

United States, Texas

Epic Clinical Research

Lewisville, Texas, United States, 75057